FDA inspection

Gelesis Srl: FDA inspection ending Feb 29, 2024

FDA inspection 1238825 · Voluntary Action Indicated (VAI) · Calimera

Key facts

Inspection ID 1238825
Firm Gelesis Srl
FEI number 3012121187
Address Via Giuseppe Verdi 188
City Calimera
Country Italy
Fiscal year 2024
Inspection end date Feb 29, 2024
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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